MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FMS PUMPS

Catalog Number 284580

Device Problem Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Biomed tech calling in complaint patient harmed looking to have equipment evaluated.When using pump something happened while knee surgery and too much pressure was placed in joint.Patient has lawyers and a lawsuit pending.Biomed tech does not have clear details on surgery claims surgery aborted.Equipment hospital owned.On 11/14: the issue may be with the tube set and not pump.Customer has sent replacement pump back from this complaint.

Manufacturer Narrative

The issue was with the tube set and not pump customer has sent replacement pump back from this complaint and will not be returning product on complaint.The complaint device is not being returned, therefore unavailable for a physical evaluation.The reported condition could not be confirmed.Further, a review into the depuy synthes mitek complaints system revealed no other complaint for this serial number that was released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.The tubeset has been reported under medwatch: 1221934-2016-10453.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: FMS PUMPS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6123611
• MDR Text Key: 60745316
• Report Number: 1221934-2016-10503
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2016
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other